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ANALYSIS: Gardasil and other HPV cervical cancer vaccine safety studies allegedly were inadequate

Dated: March 16, 2020 by Sharyl Attkisson 4 Comments

      

The following is an excerpt of an article about HPV vaccine trials in Slate.com. Click on the link at the end of the excerpt to read the full article.

A controversialย new reviewย of the HPV [cervical cancer] vaccine, which is recommended for boys and girls to prevent different types of cancer, suggests the shotโ€™s safety was not adequately tested in the clinical trials leading up to its approval.

Scientists widely agree that the vaccine has enormous potential to save lives globally, but unproven fears of side effects have hampered its uptake.ย An investigation I did for Slate in 2017 revealedย significant flaws in the manufacturerโ€™s attempt to vet its productโ€™s risks. While the new research supports these findings, anyone looking for quick conclusions can stop reading now. This is a story about process, about the messy, difficult nature of scientific inquiry, and it offers no easy answers. As Dr. Lars Jรธrgensen, who worked on the review as part of his Ph.D. studies under Dr. Peter Gรธtzsche, an outspoken critic of the pharmaceutical industry, told me, โ€œI think itโ€™s really hard to come up with a conclusion set in stone based on this kind of data.โ€

Safety concerns have been swirling around the HPV vaccine for yearsโ€”in theย news, onย socialย media, and in theย scientificย literatureโ€”but health officials across the globe have rejected those misgivings nearly unanimously. And the vast majority of studies, many of which have considered real-world data from the decade-plus the vaccine has been on the market, have failed to support the theory that it is dangerous.

To dig deeper, Jรธrgensen and his colleagues launched a sweeping analysis of drug companiesโ€™ vast study reports on the vaccine, which are largely kept confidential. And while they found much to criticize, their study ultimately revealed no solid evidence of serious side effects either. So what does this mean for people considering the HPV vaccine? Jรธrgensenโ€™s advice to parents is to continue to follow the recommendations from health authorities. In turn, he hopes those agencies will take stock of his research and use it to continue to bolster testing for new medicines, particularly those that will be used widely and prophylactically like the HPV vaccine (his full dissertation is availableย here).

The review is the most ambitious to date of the clinical trials of Merckโ€™s Gardasil and GlaxoSmithKlineโ€™s Cervarix, two HPV vaccines that have been given toย hundreds of millionsย of young people worldwide. It looked at studies that tested the vaccines against a nonvaccine solution or an already approved vaccine, a type of research design intended to gauge a treatmentโ€™s risks and benefits before it is licensed for marketing. While not conclusive, the findings do spotlight potential signs of rare neurological harms that outside experts say warrant a comprehensive look at the raw data, and they paint a damning picture of how the manufacturers evaluated their productsโ€™ safety. Dr. Tom Jefferson, Jรธrgensenโ€™s co-supervisor at the Nordic Cochrane Centre in Copenhagen, where the research was done, said safety was reported โ€œhiggledy-piggledyโ€ in the 22 industry trials he and his colleagues examined. He added that the trials were โ€œall at high risk of biasโ€ and not โ€œa fair testโ€ of the vaccines.

For instance, for nearly three-quarters of the trial participants, the reporting of serious harms was hampered by incomplete follow-up that lasted only a fraction of the studiesโ€™ durationโ€”a flawed design that was directly dictated by confidential research protocols. In the Gardasil trials, some of which ran for years, study personnel were only required to report serious medical events for 14 days following each shot. Participants who developed life-threatening or disabling disease after, say, 16 days could not count on having their ailments thoroughly assessed and reported as a potential side effect (referred to in medical-speak as an โ€œadverse eventโ€).

The truncated safety follow-up in many trials meant that they found very few serious adverse events, whereas other trials, with longer follow-up, found lots. One four-year Cervarix trial with full follow-up reported such events for 9 percent of participants, for example, compared with less than 1 percent in the largest-ever randomized placebo-controlled trial of Gardasil, which also lasted years.

Click on the link below to read the full article:

Researchers Find HPV Vaccine Trials Put Safety on the Back Burner


      
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About Sharyl Attkisson

Emmy-Award Winning Investigative Journalist, New York Times Best Selling Author, Host of Sinclair's Full Measure

Reader Interactions

Comments

  1. Robert Powell says

    March 17, 2020 at 11:34 am

    Thank you - As well, we must remove our production of drugs from China- The ability to include a nefarious item in any vaccine is wide open. The 6 in 1 has flaws according to reports.

    Reply
  2. GB says

    March 17, 2020 at 5:30 pm

    >"It looked at studies that tested the vaccines against a nonvaccine solution or an already approved vaccine, "
    In other words it was not tested against a true placebo - the standard for any scientific study. In testing the safety of arsenic, the use of cyanide as a placebo would not normally constitute sound scientific practice. Why was saline not used as a placebo? The answer is all too obvious...

    Reply
  3. A. K. says

    March 17, 2020 at 5:55 pm

    On a broader yet critical note regarding Gotzsche's work, what's essential to see is that Gotzsche has not just exposed the corrupt pharma industry but orthodox medicine in general with their various non-drug interventions and treatments.

    For example, Gotzsche has been an extremely prolific opponent of mammography. Gotzsche's book "Mammography Screening: Truth, Lies and Controversy" along with the book "The Mammogram Myth" by Rolf Hefti are the only two really extensive, independent works on the deep fraud of mammography.

    As such Gotzsche really exposes the business of conventional allopathic medicine and its government cronies as highly criminal. Which is backed by his ejection from Cochrane and the hospital he worked for many years, of course, for purely political reasons....

    Reply

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